NCT05123833

Brief Summary

To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

November 5, 2021

Last Update Submit

November 5, 2021

Conditions

Pediatric DisorderHypospadiasCongenital HypospadiaUrologic Diseases

Keywords

Hypospadias repairTunica Vaginalis FlapDartos FasciaFistula

Outcome Measures

Primary Outcomes (1)

  • Fistula

    Fistula prevalence will be recorded as a complication after surgery

    Within the first three months after surgery.

Secondary Outcomes (1)

  • Cosmetic outcome

    Within the first three months after surgery.

Study Arms (2)

Dartos Fascia

ACTIVE COMPARATOR

Dartos flap is used as a covering layer for urethra during repair of hypospadias

Procedure: Hypospadias repair

Tunica Vaginalis

ACTIVE COMPARATOR

Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias

Procedure: Hypospadias repair

Interventions

Hypospadias repairPROCEDURE

surgical repair of hypospadias

Dartos FasciaTunica Vaginalis

Eligibility Criteria

Age6 Months - 12 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales less than 12 years
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age ≥ 6 months.
  • Distal, mid-shaft penile hypospadias.

You may not qualify if:

  • Glanular hypospadias.
  • Penoscrotal, Scrotal \& Perineal hypospadias.
  • Recurrent cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

HypospadiasUrologic DiseasesFistula

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 17, 2021

Study Start

August 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)